Prospective comparison of four lymphoblastoid interferon alpha schedules for chronic hepatitis C. A multivariate analysis of factors predictive of sustained response to treatment.
OBJECTIVE
Interferon alpha (IFN-alpha) provides effective treatment in some patients with chronic hepatitis C. Since this drug is costly and causes potentially severe side effects, there is a need for clarification of the optimal dose regimen and treatment duration and of the predictive factors of long-term response to this therapy.


METHODS
Prospective, randomized study in patients with chronic hepatitis C.


METHODS
'Crespi' Division of Medicine and Centre for Liver Diseases, Niguarda Hospital, Milan, Italy.


METHODS
One hundred and forty-two patients with chronic hepatitis C were randomized to receive IFN-alpha at a dosage of 2-4 mega units/square metre of body surface area thrice weekly for 6-12 months. Eleven baseline variables that might predict sustained response to IFN-alpha were evaluated in this series. Sustained response was defined as normalization of transaminase levels observed by the fourth month of therapy and lasting for at least 6 months after treatment withdrawal.


RESULTS
According to univariate analysis, variables significantly associated with sustained response to treatment were: hepatitis C virus (HCV) genotype, treatment duration, serum HCV-RNA level and duration of hepatitis. On multivariate analysis only two of these variables were found to be independently associated with sustained response to IFN-alpha: HCV genotype (P < 0.0001) and treatment duration (P = 0.0015). In the patients infected with genotype 1b, IFN-alpha was effective only when administered at the higher dosage and for the longer period.


CONCLUSIONS
Viral genotype and treatment duration are independently related to sustained response to IFN-alpha in patients with chronic hepatitis C. The patients infected with HCV genotype 1b should receive IFN-alpha at the higher dosage and for the longer period.
Bellobuono
A
A
Crespi Division of Medicine, Niguarda Hospital, Milan, Italy.
Mondazzi
L
L
Tempini
S
S
Silini
E
E
Idéo
G
G
D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy*; D006521:Hepatitis, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011379:Prognosis; D011446:Prospective Studies; D012367:RNA, Viral / Q000032:analysis; D016896:Treatment Outcome
D016898:Interferon-alpha; D012367:RNA, Viral